Implementing Fit Kit Colorectal Cancer (CRC) Screening in High Risk Populations

NCT ID: NCT04848051

Last Updated: 2023-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-12

Study Completion Date

2022-11-21

Brief Summary

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The purpose of this study is to understand best strategies for engaging high risk populations in a primary care setting to improved adherence to colorectal cancer screening guidelines. The results will be used to identify best practices that are scalable to other high-risk populations who are due or overdue for colorectal cancer (CRC) screening.

Detailed Description

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This is a prospective implementation science study that will test 4 different approaches to increase colorectal cancer screening in a local primary care setting that provides services to individuals who are under-resourced. The interventions will include reminders from primary care providers with and without additional information and/or services to help complete colorectal cancer screening. A review of electronic medical records will be used to identify baseline information assessing risk factors and personal and family CRC history. For arm 3 of the study, participants may elect to enroll in our existing health navigation program. If so, additional baseline information will be collected, including information on Social Determinants of Health (SDOH). For arm 4 of the study, a questionnaire will be used to assess knowledge about colorectal cancer screening. The questionnaire will be repeated after the intervention (informational video). For all arms of the study, the primary outcome (engagement on CRC screening, receipt of CRC screening, results of CRC screening) will be collected through EPIC.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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CRC screening reminder

Participants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening

Group Type EXPERIMENTAL

CRC screening reminder

Intervention Type BEHAVIORAL

Participants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening

CRC Reminder & Short message

Participants randomized to the CRC Reminder \& short message arm will receive reminder that they are due/overdue for CRC screening and short message to encourage screening

Group Type EXPERIMENTAL

CRC Reminder & Short message

Intervention Type BEHAVIORAL

Participants randomized to the CRC Reminder \& short message arm will receive reminder that they are due/overdue for CRC screening and short message to encourage screening

CRC Reminder and Navigation Program

Participants randomized to the CRC reminder and navigation program arm will receive reminder that they are due/overdue for CRC screening and short message to participate in the health navigation program that will connect participants to individually tailored resources and assistance

Group Type EXPERIMENTAL

CRC Reminder and Navigation Program

Intervention Type BEHAVIORAL

Participants randomized to the CRC reminder and navigation program arm will receive reminder that they are due/overdue for CRC screening and short message to participate in the health navigation program that will connect participants to individually tailored resources and assistance

CRC Reminder & CRC education

Participants randomized to the CRC reminder and CRC education program arm will receive reminder that they are due/overdue for CRC screening and offered short educational program conducted online

Group Type EXPERIMENTAL

CRC Reminder & CRC education

Intervention Type BEHAVIORAL

Participants randomized to the CRC reminder and CRC education program arm will receive reminder that they are due/overdue for CRC screening and offered short educational program conducted online

Interventions

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CRC screening reminder

Participants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening

Intervention Type BEHAVIORAL

CRC Reminder & Short message

Participants randomized to the CRC Reminder \& short message arm will receive reminder that they are due/overdue for CRC screening and short message to encourage screening

Intervention Type BEHAVIORAL

CRC Reminder and Navigation Program

Participants randomized to the CRC reminder and navigation program arm will receive reminder that they are due/overdue for CRC screening and short message to participate in the health navigation program that will connect participants to individually tailored resources and assistance

Intervention Type BEHAVIORAL

CRC Reminder & CRC education

Participants randomized to the CRC reminder and CRC education program arm will receive reminder that they are due/overdue for CRC screening and offered short educational program conducted online

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* be 50-74 years of old at the time of enrollment
* have one valid medical encounter with CSHHC Columbus Ave. location or Dixwell location between the dates of 11/01/2019 and 11/30/2020

Exclusion Criteria

• Documented history of colorectal cancer
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beth Jones

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Cornell Scott Hill Health Center

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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2P30CA016359-39

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000030006

Identifier Type: -

Identifier Source: org_study_id

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